ICON plc, a global leader in healthcare intelligence and clinical research, is hiring a Regulatory Operations Associate in Bengaluru with flexible home-based options. This role is ideal for candidates with regulatory publishing and eCTD experience, looking to advance in global pharmaceutical regulatory operations.
Key Responsibilities
- Support regulatory submissions by preparing, assembling, and dispatching documents for authorities worldwide.
- Publish submissions and components for internal review and regulatory authority delivery.
- Ensure submission quality in both paper and electronic formats per global regulatory guidelines.
- Assemble submission packages for Health Canada, US FDA, EMA, and other international agencies using EDMS/publishing tools.
- Perform quality review of team members’ work for accuracy and compliance.
- Manage project workflows, prioritizing tasks and ensuring timelines are met.
Required Qualifications
- B.Sc. in Health Sciences, Information Technology, Computer Science, or equivalent experience.
- Minimum 2 years of regulatory operations experience in the pharmaceutical industry.
- Experience with current eCTD standards preferred.
- Understanding of global regulatory guidelines and documentation requirements.
- RAC certification is an added advantage.
Benefits
- Competitive salary package (₹6,00,000 – ₹10,00,000 per annum).
- Annual performance bonuses.
- Comprehensive health insurance for employees and dependents.
- Competitive retirement plans and life assurance.
- Flexible optional benefits like childcare vouchers, gym memberships, travel subsidies.
ICON plc is a world-leading clinical research organization known for innovation, integrity, and collaboration. With a global presence, ICON partners with top pharmaceutical and biotech companies to advance drug development and improve patient outcomes.
